Cleared Traditional

K973373 - PREVENT I

K973373 is an FDA 510(k) clearance for PREVENT I, manufactured by The Buzzz Corp.. The device is a Class 2 Physical Medicine device with product code INO cleared through the Traditional 510(k) pathway after a 171-day FDA review.

K973373 · The Buzzz Corp. · Physical Medicine device
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Feb 1998
Decision
171d
Days
Class 2
Risk

K973373 is an FDA 510(k) clearance for the PREVENT I. Classified as Chair, Positioning, Electric (product code INO), Class II - Special Controls.

Submitted by The Buzzz Corp. (Larksville, US). The FDA issued a Cleared decision on February 26, 1998 after a review of 171 days - an extended review cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.3110 - the FDA physical medicine device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Physical Medicine review framework, consistent with the majority of Class II 510(k) submissions.

View all The Buzzz Corp. devices

FDA 510(k) Submission Details - K973373

510(k) Number K973373 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 08, 1997
Decision Date February 26, 1998
Days to Decision 171 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
56d slower than avg
Panel avg: 115d · This submission: 171d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

INO Device Classification - Class 2, Special Controls

Product Code INO Chair, Positioning, Electric
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.3110
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Physical Medicine devices follow this clearance model.

Regulatory Peers - INO Chair, Positioning, Electric

All 11
Devices cleared under the same product code (INO) and FDA review panel - the closest regulatory comparables to K973373.
MERITS MODEL E SERIES LIFT CHAIRS
K060212 · Merits Health Products Co., Ltd. · Mar 2006
MEDLINE ELECTRONIC POSITIONING CHAIR
K001937 · Medline Industries, Inc. · Sep 2000
INVACARE LIFT CHAIR
K002171 · Invacare Corp. · Aug 2000
TMR48
K953342 · Pride Health Care, Inc. · Sep 1995
TMR-670
K931349 · Pride Health Care, Inc. · Jul 1993
TREATMENT TABLE, MODEL #825-100
K930262 · Biodan Medical Systems, Ltd. · Mar 1993